Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries (CTremoval)

Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.

The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Study Overview

• Status: Recruiting
• Conditions: Lung Pathologies of Unclear Etiology
• Intervention / Treatment: Procedure: Early postoperative day 0 (POD 0) chest tube removal.; Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Detailed Description

Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Dorn, PD; Phone Number: 0797696216 0041 31 632 37 45; Email: patrick.dorn@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3013
    • Recruiting
    • University Hospital of Bern, Inselspital
    • Contact: Patrick Dorn, PD; Phone Number: 0797696216 0041 31 632 37 45; Email: patrick.dorn@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
2. Thoracoscopic pleural biopsy
3. Signed consent
4. Age of majority

Exclusion Criteria:

1. Anatomical resection
2. Empyema
3. Pleural effusion
4. Pleurodesis
5. Vulnerable persons (Pregnant women, Children and adolescents)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test group; Test group: The patients of the study group are getting their chest tube removed according to the investigators' current airleak protocol (Flow <20 mL/ min on digital suction device) but already in the operating room immediately following wound closure (Postoperative day 0 (POD0)). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).	Procedure: Early postoperative day 0 (POD 0) chest tube removal.; Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow <20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).
Other: Control group; In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day 1 (POD1).	Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).; Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Pneumothorax requiring chest tube reinsertion	Number of patients with pneumothorax requiring chest tube reinsertion after removal of initial chest tube	Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)
2. Pleural effusion requiring thoracocentesis	Number of patients with pleural effusion requiring thoracocentesis after removal of first chest tube	Pleural effusion 2 hours after chest tube removal between POD 0 and 30
3. Prolonged air leak > 5 days	Number of patients with persisting air leak longer than 5 days	Chest tube removal between POD 6 and 30
4. Re-admission or reoperation due to pleural complication	Number of patients re-admitted to a hospital after first hospitalization	Up to 1 month after first operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS)	Number of patients with cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) after operation	Up to 1 month after initial operation
2. Re-operation	Number of patients requiring a re-operation after initial operation	Up to 1 month after initial operation
3. Length of drainage (days)	Average of time with chest tube in site	Up to 1 month after initial operation
4. Length of stay (days)	Average of time in hospital	Up to 1 month after initial operation

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Study Director: Patrick Dorn, PD, Chief, Department of General Thoracic Surgery, Inselspital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EROCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be included in a manuscript and published in a journal to share the data and results of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No